A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer.

Roche

Status and phase: Completed; Phase 4

Conditions: Colorectal Cancer

Treatments: Drug: capecitabine [Xeloda]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00502671

ML20592

Details and patient eligibility

About

This single arm study will evaluate the safety profile of Xeloda as monotherapy for adjuvant treatment of colon cancer. All patients will receive Xeloda 1250mg/m2 p.o. twice daily as intermittent treatment (3 week cycles consisting of 2 weeks of treatment followed by 1 week without treatment). The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Enrollment: 228 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• colon cancer (Dukes stage C);
• surgery, with no evidence of remaining tumor;
• ECOG performance status of <=1.

Exclusion criteria

• previous therapy for currently treated colon cancer;
• any evidence of metastatic disease;
• history of other malignancy within last 5 years;
• clinically significant cardiac disease.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

228 participants in 1 patient group

1

Experimental group

Treatment:

Drug: capecitabine [Xeloda]